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Category: Part 11

06 Jul 2020

FAQ: Compliance in Paperless Research Systems

Why does compliance matter when using an electronic system?

Many established electronic systems provide research organizations a means to hold and secure valuable clinical research documents and data in a paperless environment that allow for greater site and sponsor efficiencies. These systems may include capabilities that span from recruitment tools, enrollment tracking, calendaring and appointment scheduling, data collection and regulatory document management. There are many things that you need to consider when transitioning to electronic systems, but perhaps one of the most important questions to ask is, are your electronic systems compliant with FDA 21CFR Part 11 guidance as well as your local, state and federal data privacy laws surrounding Protected Health Information (PHI)?

Compliance is vital to your organization, especially during a time when our industry is rapidly adapting to electronic systems. Maintaining a state of audit readiness is important, but it is very challenging to know all of the rules and regulations that must be followed and what technical requirements these systems must include in order to keep you compliant. The need for remote monitoring of data that is no longer held on paper is the new norm, but electronic systems must, at a minimum, be able to ensure that data is Attributable, Legible, Contemporaneous, Original, and Accurate, otherwise known as ALCOA. Systems that ensure ALCOA as well as the complex back-end standards that ensure compliance and security regulations, provide assurances of FDA and sponsor acceptance of data and documents held and managed within these systems.

For electronic systems to work effectively, allow staff to efficiently operate in a way that conforms to your established SOPs, ensure data privacy and security, and meet industry Good Clinical Practices (GCPs), certain capabilities should be standard, including:

  • Audit trails detailing the date, time and details associated with each user’s additions, edits or removals of data and/or documents
  • Encryption of data while stored on local or remote drives (at rest) and within the user application (in motion)
  • The ability to generate certified copies of records while maintaining the integrity of the original record
  • The ability to provide record retention while preserving the digital format over a long time (at least 15 years in most cases)
  • Customizable forms and filing templates
  • Integrations with data warehouses such as CTMS to reduce redundant data entry and streamlined linking to financial tracking systems

The Shift to eREGULATORY and eSOURCE Systems:

When using compliant eREGULATORY and eSOURCE systems, your site staff, the Sponsor/CRO, the FDA, IRBs and any other third-party auditors must have quick access to documents, data, audit trails, document versioning and expiration dates, eSignature status reports, source data and so much more. Due to technological advances, general correspondence and essential documents provided through the mail or other courier service are becoming a thing of the past as online portals are the new model for document and data sharing.

While industry processes are shifting almost entirely to online electronic systems, the flexibility and ease for both the Sponsor and Research Organizations are rapidly increasing. This transition to electronic systems allows clinical trials to run more seamlessly with an organized presentation of data, ease of access, proper utilization of time, increased compliance of security, privacy, and GCP standards, not to mention less travel for monitors reviewing data.

When it comes to compliance, what are some essential features to look for in a paperless system?

Important features to consider in any electronic system that you may be considering should include, at a minimum:

  • Documented Part-11 and HIPAA Compliance
  • Limited access to data and documents to authorized users based on role
  • Complete Audit Trials
  • Compliant Electronic Signature Processes
  • Automated conversion or export methods for managed documents
  • Documented validation processes for Auditor Review
  • Remote monitoring and query systems

Moving from a paper-based system to an electronic system plays a pivotal role in moving clinical research forward and into a technologically advanced world. If you are interested in going paperless with RealTime’s compliant, feature-rich and user-friendly systems, give us a call and our team will take you on a complete tour! Schedule a FREE DEMO by calling (210) 852-4310 or fill out the form below.

26 Jun 2020

5 Things to Look for in an eRegulatory System

Due to increasing demand and shift to paperless research systems, it is vital to ask the right questions when searching for a site-based eRegulatory system. Sites can utilize eRegulatory systems to streamline regulatory processes, maximize cost-effectiveness, and make study information more accessible. These are some basic questions to ask when searching for an eRegualtory system.

What should I look for in an eRegulatory system?

Comparing the features and capabilities of eRegulatory systems is critical. Below are some essential things to consider as you evaluate various eRegulatory systems available:

User Experience

User experience can make a huge difference when accessing your eRegulatory files. An eRegulatory system should provide an intuitive and user-friendly experience. Everything from navigation, document versioning, eSignatures, and more are all features that make the user’s job easier.

Monitoring Portal

Today, a remote-monitoring portal in clinical trials can be an excellent benefit for all parties. These portals allow sites to upload regulatory documents for remote review, provide for query management, document versioning, document downloads, and more.

Secure Centralized Filing

An essential factor to consider is the safety of your documents. Your eRegulatory system should highly secure and meet or exceed all industry standards for data hosting and security.   These standards include data encryption, redundant storage, robust back-up systems, disaster recovery planning, third-party penetration testing, and more.

Compliance with Part-11 and HIPAA

Your eRegulatory system should meet FDA Part-11 and HIPAA compliance, which includes essential features such as user audit trails, software validation, compliant eSignatures, and much more. These compliance standards are verified by the FDA and must be present during an audit.

Customer Support

When making the switch to paperless eRegulatory systems, you need guidance and support to ensure a smooth transition.  Ensure that your vendor not just claims to provide excellent support but has numerous customer references to back it up.  Additionally, all training and support services offered by the vendor should be clearly defined in your software agreement.

When choosing an eRegulatory system, ask for a complete demo. A full demo can give you a solid understanding of the features, capabilities, and user-friendliness of the software and upcoming features on the vendor’s product roadmap. Finally, before signing, look out for hidden storage fees or long-term, binding contracts.

User-friendly features, excellent customer support, and remote-monitoring capabilities are the tip of the iceberg when it comes to RealTime-eDOCS as an eRegulatory system. If you are interested in scheduling a free demo of RealTime-eDOCS, an industry-leading eReg solution, give us a call at (210) 852-4310 or click below!

09 Jun 2020

Keeping research compliant amid the COVID-19 crisis

Many clinical research sites and sponsors are accepting new paperless processes in light of the novel COVID-19 crisis. With the inevitable switch to paperless clinical trial systems, one can hope that the same industry guidelines are equally enforced.

With any process, there are rules; the clinical research process is no different with most prescription drugs taking years to hit the market. Each part of the research process involves a multitude of regulatory guidelines that ensure the safety, security, and ethical standards of clinical trial data. Let’s cover the main checkpoints that certify your clinical trial systems’ compliance.

General Data Protection Regulation (GDPR)

The General Data Protection Regulation 2016/679 (GDPR) is an EU law that enforces data protection and privacy in the European Union and the European Economic Area. It addresses the outbound transfer of personal data to other countries. Your clinical trial software should enforce GDPR guidelines if you are conducting trials or transferring data from the EU and EEA areas.

FDA CFR Part-11

Essentially, 21 CFR Part 11 regulations define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. This guideline allows companies to replace any paper record or hand-written signature with an electronic record/signature. The truth is every investigator’s site already has electronic records, but most companies are so unsure of Part 11 compliance that they resort to printing paper in fear of being non-compliant with regulations. Ensuring your clinical trial software meets this standard is crucial.

HIPAA Compliant

The Health Insurance Portability and Accountability Act (HIPAA) safeguards electronic protected health information (ePHI). This is important for clinical researchers as it establishes the circumstances in which they can disclose ePHI. Your clinical trial systems should unquestionably safeguard ePHI.

Are your clinical trial systems compliant?

Now that you understand the significance of compliance in your clinical trial systems, it might be time to ask: Are your clinical trial systems compliant?

RealTime-eSOURCE and RealTime-eDOCS offer exemplary built-in parameters that enforce these compliance standards. Each solution exhibits GDPR, FDA Part-11 HIPAA Compliance measures that allows you the freedom to conduct research remotely while having peace of mind.

So, are you ready to start your clinical research compliance journey? Get started by scheduling a free demo with a RealTime expert! Call us at 210-852-4310 or fill out the form below!

31 Mar 2020

Utilizing Remote Monitoring Study Portals Through a Pandemic

During this challenging time, maintaining clinical trial progression is a novel challenge as on-site data and regulatory reviews are either impossible or extremely limited. Travel limitations and “stay home” initiatives across the country have hindered the way clinical trial data is handled. Many clinical research sites and sponsors are left without the data records needed to conduct safe and timely trials.

RealTime’s eSOURCE and eDOCS could be the solutions you are looking for to maintain visibility, data integrity, subject safety, and keep operations moving. RealTime systems provide complete monitoring portals to review eSOURCE data and eRegulatory data. These portals allow sites to upload their source documents and regulatory documents for remote review, provide for query management, document versioning, document download, and more. Here are the key features that RealTime can rapidly deploy:

  • Source Document and Regulatory Monitoring portals – Online access allows Sponsors to collaborate more effectively during trials and streamlines monitoring activities.
  • Query Management – Sponsors can review, track, and issue queries on records from the monitoring portal. Sites communicate directly to the monitor for a quick resolution.
  • Document Version Control – Source documents can be uploaded by sites using our document control feature.
  • eSignatures – Electronic signatures dramatically increase efficiency when gathering staff/doctor signatures. This feature also maximizes subject safety oversight by allowing more timely doctor assessments on lab reports, ECGs, and other critical documents.
  • Part-11 Compliance – Our systems are secure, validated, and ready to go! Complete audit trails and data controls are maintained within the system for users to reconstruct the time of events and prevent human errors during data collection. These features improve accountability and data integrity.
  • Secure Cloud Hosting – All records are stored with a thorough data security/backup plan and encrypted for maximum security.
  • Built-in Reports and Notifications – Quickly review queries across all records, including query statuses.

 

Here at RealTime, it is our goal to help guide you through this moment and get your clinical trials back on track. We are here to help. Give us a call at 210-852-4310 or CONTACT US to learn more!

30 Mar 2020

San Antonio based software company keeping clinical research moving amid COVID-19 crisis

San Antonio, TX – As COVID-19 clinical trials start to ramp up around the country, the research industry has struggled to continue operating. As more and more cities implement orders to shelter in place, the way clinical trials are monitored has faced a challenge.

RealTime Software Solutions, a San Antonio based software company, is giving the industry a facelift that may forever change how research is conducted. Clinical trial monitors have historically visited research sites in person, collecting and monitoring crucial trial data. As most (if not all) sponsors and contract research organizations (CRO) have halted travel, and many sites limiting access to their locations, the need for other options have emerged.

“Sponsors and CRO’s are facing serious challenges in gaining access to study data and regulatory documents for important monitoring activities,” says Rick Greenfield, CEO of RealTime. “A rudimentary, inefficient and non-regulatory compliant solution, is for sites to scan and email these confidential and highly sensitive documents to the monitors for review.”

In steps RealTime.

“RealTime is now implementing emergency measures and spinning up complete portals for sponsors and CRO’s to deliver monitoring systems to their sites,” says Greenfield. “This will allow a quick and easy option for sites to upload data source and regulatory documents for review.  These systems are FDA Part-11 and HIPAA compliant, and provide excellent categorization and version control of uploaded study data for efficient monitoring.”

RealTime portals also include two-way data monitoring communication to maintain a strong connection between the sites and study-management personnel.

“This is such a challenging time for the entire world, and we are all trying to make sense of the massive change that has taken place in our society and the global economy,” says Greenfield.  “Just like everyone else, we are looking for ways to help and we are thankful to have been working for the past several years on systems that can provide a major benefit to the clinical research industry at this most critical time of need.  I urge all Sponsors and CROs to reach out to RealTime as we can deliver a complete monitoring portal to run multiple clinical trials for an unlimited number of sites within 48 hours.  We can train on the usage and have these systems fully operational in less than a week.”

RealTime has been at the forefront of clinical research technology, providing cutting-edge software to an industry that has been somewhat antiquated. This latest technology may change how trials are conducted and monitored, allowing a more streamlined approach.

“If we can keep clinical research moving with absolutely no additional risk to sponsor/CRO staff, then we can keep searching for better treatments and cures when they are most needed,” says Greenfield.

To learn more, visit realtime-ctms.com or call (210) 852-4310.

About RealTime

RealTime is a leader in advanced clinical research software with leading Clinical Trial Management Systems (CTMS), eSOURCE and eDOCS portals for completely paperless clinical trials.  The value of these systems is shining bright during this difficult time and allowing clinical research to continue for the benefit of medical advancements to include COVID-19 vaccine and treatment studies.

Call RealTime today at (210) 852-4310 or email info@realtime-ctms.com to learn more about remote monitoring portal delivery.

19 Apr 2019

ACRP 2019 – Key Takeaways (and Bandanas)

Each year, RealTime attends a variety of conferences around the globe in hopes of aiding clinical research professionals, sites, sponsors and CROs on their paperless journey. RealTime attended ACRP in Nashville, Tennessee this April and the team had the opportunity to network with professionals in the industry while gaining insight into the realm of clinical research technology. Did you get your RealTime-Bandana?!

RealTime’s CEO, Rick Greenfield discussed one of the hottest topics at the conference:

The Paperless Site –eSOURCE and eREG

In a follow-up conversation with Rick Greenfield, we asked him a few questions on his takeaways from the conference.

RealTime CEO discusses the shift to paperless sites and the challenges sites face when transitioning to paperless systems like eSOURCE and eDOCS.

How do you feel that RealTime is contributing to the shift to Paperless Sites?

“The RealTime-SOMS (Site Operations Management System) is the first of its kind, combining our leading CTMS, eSOURCE, eDOCS, SitePAY, and TEXT into one system. The RealTime-SOMS can also be accessed through the RealTime-MobileAPP, which can essentially eliminate the need for paper and allow site staff and investigators to perform most tasks with a smartphone or tablet.  While developing these paperless solutions has been challenging, seeing the success that RealTime sites are having with the shift to eSOURCE and eDOCS is incredibly rewarding.  I only wish that I would have had these tools when I was running my own clinical research site.”

What was your favorite part of ACRP?

“ACRP was an incredible experience for RealTime.  The best part was seeing how RealTime and the many other vendors at ACRP that are working to change the industry by helping Sites, Sponsors and CROS achieve greater efficiency and better outcomes. It is a privilege to network with other industry professionals and to participate in the search for innovative solutions to the obstacles our industry faces every day.”

Do you feel that Site-Based Paperless Systems will change our industry for the better?

“They already are! The shift to site-based paperless systems is already happening at an astounding rate, and the benefits of these new systems are already being realized by all parties involved in the conduct of clinical trials.  As the shift continues, the clinical research industry as we know it will be faster and more efficient than ever.”

If you missed RealTime at ACRP, here is a list of our upcoming conferences:

  • MAGI EAST | May 5 – 8th | Boston, Massachusetts
  • DIA | June 23 – 27th | San Diego, California
  • SCRS | October 11 – 13th | Hollywood, Florida

Learn more about the RealTime solutions including eSOURCE, eDOCS, CTMS, TEXT, SitePAY and GlobalPAY that are leading our industry into the future.

Click HERE or call (210) 852-4310 to see RealTime products up close!

01 Mar 2019

6 New Features of the RealTime-CTMS MobileAPP

From text messages to video conference calls, mobile devices have become part of an everyday routine. Consequently, mobile device usage has become more evident in the clinical research setting. Utilizing electronic devices can improve efficiency and streamline research data across your site.  Implementing the right mobile software can drastically enhance the study process.

The new RealTime-MobileAPP delivers innovative new features that place a Site Operations Management System (SOMS) in the palm of your hands. With a tablet or phone, you can access studies, subjects, calendars, contacts, source documents, regulatory documents and much more. So, here’s an inside look at our latest updates!

 

1. Face Recognition

One of the most innovative features of the MobileAPP is face ID recognition. Rather than logging in with password credentials, setting up face recognition can make remembering passwords a thing of the past while also streamlining the eSignature process for documents.

2. Calendar and Scheduling

Users can access various calendars to keep their schedules organized. Manage events from the MobileAPP and easily stay on top of your appointments.

3. System Notifications

Receive push notifications for calendar events, eSOURCE communication and eSignature requests. All notifications are management on a single notification page.

4. Streamlined Subject Management

Investigators and staff can now refer subjects through the Subject tab or from the main menu. Referrals from the MobileAPP feed directly into the CTMS to initiate recruitment processes. Users can also search for qualified subjects based on history or indication. The subject profile page allows users to view contact attempts, demographics, and study visits in one place.

5. eDOCS and eSOURCE Integration

Investigators and staff can access eDOCS to view/sign study regulatory documents.  Accessing eSOURCE will allow users to view enrolled subjects and collect visit data straight to their iPad or tablet.

6. Study Contacts

Users can access contacts directly from the MobileAPP. Add professional contacts or staff contacts for easy communication.

So, what are you waiting for?

Start accessing subject profiles, calendars, source documents, and more through the RealTime-MobileAPP! Streamline your site communication and increase efficiency.

Schedule a demo with us by calling (210) 852-4310.

22 Feb 2019

Behind the Software with Nathan Levens

Our goal as a team is to give back to clinical researchers by creating software that is more efficient, reliable, and easy to use. This month, we are featuring a team member that has gone above and beyond for our customers, Nathan Levens.

Nathan has over 10 years’ experience in the clinical research industry. He is currently the Product Manager for our eSOURCE product at RealTime Software Solutions and teaches sites how to transition from paper-based regulatory and source documentation processes to electronic solutions.

You might be wondering what Nathan is like behind the software. We had the chance to ask him a few questions to get to know him a little better!

What was your favorite TV show growing up?

Growing up, I had a lot of favorite TV shows, but I watched Saved by the Bell reruns every day after school for several years. I thought Zack Morris was the coolest guy in the world.  Especially when he got his first mobile phone and carried it in his backpack.  I was still using a wall-mounted phone with a 10 ft cord that stretched across the room.

What’s the best piece of professional advice you’ve ever received?

I’ve received a lot great advice from books, coworkers and people I consider mentors.  One piece of advice that comes to mind is that we should ‘work to learn’ rather than simply ‘work to earn’. There are a lot of jobs that provide a paycheck, but it’s important to be selective when taking a position with a company.  Go for the jobs that force you to learn new skills.  As you learn new skills, more opportunities will present themselves throughout your career.

What’s your favorite 90’s jam?

Too many songs to choose from. The 90’s were awesome. I watched MTV every morning before school and liked almost every song that hit their top 20 list.

What’s the coolest or most interesting thing you’re working on right now?

That would be the product that I manage, RealTime-eSOURCE. This type of product is changing the way research sites collect study data and the possibilities are endless with this product.  I’m excited to see how the product shapes the industry in the next 5-10 years.

If you could meet any comic book superhero, who would it be and why?

Easy… Batman.  No explanation needed.  It’s Batman.  He can beat anyone, even Superman.

What are your biggest pet peeves?

I’ve never had pet peeves, but I do have a pet Yorkie.  Just kidding but I do have a Yorkie!  The only thing I can think of that bothers me is when fellow drivers decide not to use their blinker light in traffic and subsequently get mad at me for not realizing they want in my lane.  I’ve learned a lot about breathing to relax in traffic.

What’s your favorite famous or inspirational quote?

I’ve never been attached to famous quotes, but I like funny ones.  “Life’s a garden.  Dig it!” – Joe Dirt

What are the values that drive you?

I’m sure I sub-consciously subscribe to a lot of values but I usually just keep things simple in my life. I make sure I’m doing my best at whatever I set my mind to, and I value my relationships with friends and family.

What books/podcasts are you into at the moment?

I like to get nerdy so I’m currently listening to StarTalk Radio with Neil deGrasse Tyson.  I’m also reading Ego is the Enemy by Ryan Holiday.

What is the most inspiring part of your job?

It’s the customer testimonials that inspire me.  As a product manager, I love the fact that I get to help create solutions that make other people’s lives easier.  It’s a great feeling when a customer expresses how happy they are for choosing RealTime. These testimonials inspire me to help more customers.

Stay tuned for more interviews as we get to know some of the team behind RealTime Software Solutions. If you are interested in scheduling a demo for eSOURCE, or any of our other solutions, call (210) 852-4310 or fill out a CONTACT FORM.

29 Jan 2019

Behind the Software with Elise Tawfiq

RealTime is dedicated to providing exceptional support, which is why we search for team members that go above and beyond for our customers. Our goal as a team is to give back to clinical researchers by creating software that is more efficient, reliable, and easy to use. This month, we feature one of our amazing team members, Elise Tawfiq.

Elise joined the RealTime team in ­­­­2015 and has over 15 years’ experience in the clinical research industry. She is currently the Product Manager for the GlobalPAY and TEXT programs at RealTime Software Solutions. Elise now teaches sites how to leverage technology to succeed in a challenging business environment.

To get to know her better, we’ve asked her some fun questions!

1. What is your favorite drink?

Coffee

2. What is the best piece of advice you could give to a younger version of yourself?

The only person you must compete with is yourself.

3. If you could invent a holiday, what would it be?

Couch & PJ’s Appreciation Day….Dedicated to comfort and cinema!

4. What is your favorite 80’s song? 80’s movie?

80’s Song: With or Without You-U2   80’s movie: Can’t Buy Me Love

5. Finish this sentence. On Sunday mornings, you can usually find me…

Spending time with my family

6. Cats or dogs?

Both!

7. If you could have any superpower, what would it be?

To read people’s minds

8. What are the values that drive you?

Integrity, Determination, and Compassion

9. What is your favorite Disney movie?

Aladdin

10. What is the most inspiring part of your job?

Witnessing sites grow and improve by using techniques and technology that I have assisted them implement.

Stay tuned for more Behind the Software as we get to know some of the team behind RealTime Software Solutions. If you are interested in scheduling a demo for GlobalPAY, SitePAY, TEXT, or any of our other solutions, call (210) 852-4310 or fill out a CONTACT FORM.

02 Jan 2019

A Message from the CEO: 2018 in Review

This year has been an exciting journey for the entire RealTime team!  As we look back at our 2018 progression, it’s hard to imagine that twelve months have already flown by.

In 2018 we accomplished major new advancements in ALL of our systems. The RealTime SOMS (Site Operations Management System) is one-of-a-kind, and the solutions that make up the RealTime-SOMS are all industry-leading products as standalone solutions!

Here is a quick run-down of some of the major accomplishments of 2018:

CTMS (Single-Site, Multi-Site and Enterprise):

  • Improved interface
  • Advanced overhead calculations
  • Expanded QC functions
  • New Study Progress Tracking features
  • Integration with Devana Ignite for Sites
  • And so much more!

 

eDOCS and eDOCS-Lite:

  • Document Cart for picking any number of documents across multiples studies for signing or sending
  • Bulk Signing – Staff and Doctors can now sign numerous documents with a single eSignature
  • Faster Signature Processing to keep site operations moving at record pace
  • Numerous updates to our custom Outlook Add-in

 

RealTime-TEXT:

  • Multi-lingual texting
  • International texting in New Zealand, Australia, Europe, and Canada
  • Mass texting capabilities for study recruitment

 

GlobalPAY:

  • GlobalPAY is going worldwide and has seen major interface improvements for Sponsors/CROs and Sites around the globe!

 

eSOURCE:

  • Launched in summer 2018, eSOURCE is our fastest growing product ever!
  • Advanced MobileAPP capabilities
  • Complete integration with CTMS and eDOCS
  • Complete Monitoring Portal
  • Patient Portal for online eSOURCE questionnaires
  • Next year we plan to implement advancements such as connection to EDC, advanced data controls, and more.

 

All of RealTime’s success is made possible by our valued customers that inspire every solution we develop. In 2019, we will continue to listen to our remarkable customers around the world to further our mission of leading the industry with new advancements and features that were once only dreamt of.

Sincerely,

Rick Greenfield, CEO